Medication info
Glivin Tablet 400 mg (Imatinib Mesylate)

Glivin Tablet 400 mg (Imatinib Mesylate)

Prescription medicationTabletOral
Ingredient · strength
Imatinib Mesylate›478mg / 1 tablet
Manufacturer / importer
Dong-A ST Co., Ltd.
Appearance
Dark yellow-brown oval film-coated tablet
Packaging
30 tablets/PTP
Approval status
Active

MFDS item code 201307124 · Approved 2013.04.30 · Insurance code 642506930

Summary

Main use
Treatment of hematologic diseases (e.g., chronic myeloid leukemia), gastrointestinal stromal tumors, and dermatofibrosarcoma protuberans
Who takes it
Adults · Children
Adult dose
For adults with chronic myeloid leukemia (CML), a dose of 400mg once daily is recommended for Philadelphia chromosome-positive chronic-phase disease, and 600mg once daily for accelerated- or blast-phase disease. For adults with gastrointestinal stromal tumors (GIST), a dose of 400mg per day is recommended. The recommended dose is 400mg per day for myelodysplastic/myeloproliferative diseases; for hypereosinophilic syndrome/chronic eosinophilic leukemia, the dose may be increased from 100mg to 400mg per day. For recurrent or metastatic dermatofibrosarcoma protuberans, take 800mg per day (400mg twice daily). Take the dose with food. Take 400mg or 600mg once daily, and 800mg twice daily. Patients who have difficulty swallowing the film-coated tablets may take them suspended in water or apple juice.
Child dose
For pediatric patients with chronic myeloid leukemia, a dose of 340mg/m2 per day based on body surface area is recommended. The total daily dose should not exceed 600mg and may be given once daily or divided into 2 doses, in the morning and evening. Pediatric patients may take the dose once daily or in 2 divided doses. For dosage adjustment, the pediatric dose may be reduced from 340mg/m2 to 260mg/m2 or 200mg/m2.

Ingredients

Manufacturer
Dong-A ST Co., Ltd.

Efficacy & effects

Treatment of hematologic diseases (e.g., chronic myeloid leukemia), gastrointestinal stromal tumors, and dermatofibrosarcoma protuberans

  • Chronic myeloid leukemia
  • gastrointestinal stromal tumors
  • myelodysplastic syndromes
  • myeloproliferative diseases
  • hypereosinophilia syndrome
  • chronic eosinophilic leukemia
  • and dermatofibrosarcoma protuberans.
View approved original text

This medication is used for the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors, and certain rare diseases related to the bone marrow and skin with confirmed specific gene rearrangements. It enhances hematological and cytogenetic responses in patients with chronic myeloid leukemia and slows disease progression. For patients with gastrointestinal stromal tumors, it prevents recurrence and is also used as adjuvant therapy after surgery. Moreover, it is effective in certain rare blood and tissue disorders, improving tumor response rates and hematological responses. Tailored to the individual patient's situation, this medication helps achieve positive therapeutic outcomes.

How to take

Adult dose

For adults with chronic myeloid leukemia (CML), a dose of 400mg once daily is recommended for Philadelphia chromosome-positive chronic-phase disease, and 600mg once daily for accelerated- or blast-phase disease. For adults with gastrointestinal stromal tumors (GIST), a dose of 400mg per day is recommended. The recommended dose is 400mg per day for myelodysplastic/myeloproliferative diseases; for hypereosinophilic syndrome/chronic eosinophilic leukemia, the dose may be increased from 100mg to 400mg per day. For recurrent or metastatic dermatofibrosarcoma protuberans, take 800mg per day (400mg twice daily). Take the dose with food. Take 400mg or 600mg once daily, and 800mg twice daily. Patients who have difficulty swallowing the film-coated tablets may take them suspended in water or apple juice.

Child dose

For pediatric patients with chronic myeloid leukemia, a dose of 340mg/m2 per day based on body surface area is recommended. The total daily dose should not exceed 600mg and may be given once daily or divided into 2 doses, in the morning and evening. Pediatric patients may take the dose once daily or in 2 divided doses. For dosage adjustment, the pediatric dose may be reduced from 340mg/m2 to 260mg/m2 or 200mg/m2.

Precautions

This medication should not be used in patients with known allergies to specific components. Women who are pregnant or may become pregnant should refrain from taking this medication. Women who are breastfeeding should also avoid this medication. It should be used cautiously in patients with impaired liver or kidney function, who require close monitoring by a physician. Patients with a history of heart disease, heart failure, or kidney failure require special attention during treatment, and should seek immediate treatment if symptoms arise. In patients with hypereosinophilia syndrome who have heart infiltration, there is a risk of cardiac shock or left ventricular dysfunction during initial administration, necessitating caution. Patients who have undergone thyroid surgery should regularly check their levels of thyroid-stimulating hormone, as they may experience hypothyroidism. In pediatric patients prior to puberty, growth retardation has been reported, and growth status should be regularly monitored during long-term use. Tumor lysis syndrome may occur, so appropriate treatment for dehydration and high uric acid levels should be addressed before administration. Patients who are carriers of hepatitis B must undergo viral testing prior to this medication and closely monitor their liver condition during and after treatment. While taking this medication, various side effects such as decreased blood cell counts, indigestion, swelling, headaches, nausea, vomiting, muscle pain, diarrhea, rashes, and fatigue may occur, hence symptoms should be discussed with healthcare professionals. Depending on the severity of side effects, dosage adjustment or discontinuation may be necessary. This medication carries risks of serious hepatic toxicity, renal failure, hypophosphatemia, serious respiratory adverse reactions, and tumor lysis syndrome; therefore, regular monitoring is important.

Side effects

  • Neutropenia
  • thrombocytopenia
  • anemia
  • headache
  • dyspepsia
  • edema
  • weight gain
  • nausea
  • vomiting
  • muscle cramps
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  • musculoskeletal pain
  • diarrhea
  • rash
  • fatigue
  • abdominal pain
  • hepatotoxicity
  • acute renal failure
  • hypophosphatemia
  • severe respiratory adverse reactions
  • tumor lysis syndrome
  • growth delay in children
  • hypothyroidism
  • cardiogenic shock
  • left ventricular dysfunction
  • reactivation of hepatitis B

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain storage temperatures between 1 to 30 degrees Celsius to ensure the efficacy of the medication.

Appearance and packaging

Appearance

Dark yellow-brown oval film-coated tablet

Package unit

30 tablets/PTP

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.